The following data is part of a premarket notification filed by Dongguan Rongfeng Medical Co., Ltd. with the FDA for Electric Breast Pump.
| Device ID | K212884 |
| 510k Number | K212884 |
| Device Name: | Electric Breast Pump |
| Classification | Pump, Breast, Powered |
| Applicant | Dongguan Rongfeng Medical Co., Ltd. Room 201, No. 7 Xiangyuan Road, Shujiu Changping Town Dongguan, CN 523570 |
| Contact | Qianqian Yu |
| Correspondent | Reanny Wang Shenzhen Reanny Medical Devices Management Consulting Co Ltd Room 1407, Jingting Building, Dongzhou Community, Guangming Street, Guangming District Shenzhen, CN 518107 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-10 |
| Decision Date | 2022-01-20 |